The Combination of Diosgenin, Vitamin D, and α-Lactalbumin Normalizes the Menstrual Cycle in Women with PCOS of Phenotype D: A Pilot Clinical Study.

Michele Russo, Giuseppina Porcaro, Cesare Aragona, Gabriele Bilotta, Massimo Di Liberto, Vittorio Unfer

Journal: Nutrients 2025;17(23):

PMID: 41373986

Abstract

BACKGROUND

The study aimed to evaluate the efficacy of a combination of Dioscorea villosa (containing diosgenin), vitamin D, and α-lactalbumin, in women with Polycystic Ovary Syndrome (PCOS) phenotype D. The primary objective was to investigate improvements in menstrual cycle regularity.

METHODS

A total of 24 women aged 22-34 years with PCOS phenotype D received daily supplementation with 600 mg Dioscorea villosa (120 mg diosgenin), 100 mg α-lactalbumin, and 50 μg vitamin D for six months. Clinical and biochemical assessments, including hormonal profiling and menstrual cycle monitoring, were conducted at baseline (T0), after 3 months (T1), and after 6 months (T2).

RESULTS

The treatment led to a statistically significant improvement in menstrual cycle regularity: eumenorrhea was achieved in 50% of patients at T2, compared to 0% at baseline. Significant changes were also observed in luteinizing hormone (LH), follicle-stimulating hormone (FSH), and the LH/FSH ratio, alongside a reduction in insulin and HOMA-index at T1. No adverse events were reported.

CONCLUSIONS

The combination of Dioscorea villosa, vitamin D, and α-lactalbumin promotes menstrual cycle regularization in women with PCOS phenotype D. The positive result suggests a beneficial role of the treatment when administered to this specific subtype of PCOS and supports the use of targeted nutraceutical therapy as an alternative to conventional treatments, especially in non-hyperandrogenic PCOS patients.

Address: R&D Department, Lo.Li. pharma s.r.l., 00156 Rome, Italy.; The Experts Group on Inositol in Basic and Clinical Research and on PCOS (EGOI-PCOS), 00156 Rome, Italy.; Sotherga Clinic, 20121 Milan, Italy.; The Experts Group on Inositol in Basic and Clinical Research and on PCOS (EGOI-PCOS), 00156 Rome, Italy.; Systems Biology Laboratory, Department of Experimental Medicine, Sapienza University, 00163 Rome, Italy.; Alma Res Fertility Center, 00198 Rome, Italy.; Complex Operating Unit of Gynecology, Obstetrics of the "Abele Ajello" Hospital, 91026 Mazara del Vallo, Italy.; The Experts Group on Inositol in Basic and Clinical Research and on PCOS (EGOI-PCOS), 00156 Rome, Italy.; Department of Gynecology and Obstetrics, UniCamillus-Saint Camillus International University of Health Sciences, 00131 Rome, Italy.
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